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The Future of BioPharma blog provides timely coverage of news that directly impacts the business strategies of the biotech, pharmaceutical and medical device industries. In addition to news coverage, the Future of BioPharma blog features live event coverage from IIR's Biopharmaceutical and Healthcare division.

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Friday, February 27, 2015

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing. Today, he shares the importance of disposable membrane chromatography systems for mAb purification.

Has disposable technology been tested on a large scale yet at Patheon?

As I said, there are two parts. One is the clarification and we are testing Clarasolve Filters and he second part is we are replacing chromatographic columns with membranes. So, for our process --- in essence, we are not reinventing the wheel because Clarasolve Filters are from Millipore and the membranes that we are using are from Natrix, one of our collaborators.

So, we have not reinvented the wheel. What we have done is we have merged both these technologies to come up with a hybrid process which is far more effective and far cheaper compared to the classical platform or traditional platform methods.

Having said that, we have not yet tested the full process at scale. But, Clarasolve has been using multiple commercial products and they are being used multiple times successfully both by Patheon and by many other companies, as well. And Natrik members are also employed in many of the clinical trials. So, individual contributors are already being tested and are proven in the market that they are liable to be used for the production of human injectibles. We have mix them to produce the whole process and, of course, --- as you know, Patheon is a CDMO and we have got ample opportunities to test them and we are in the process of testing them. But, of course, they are not yet tested at scale.